intro

There is a known problem with clinical trials – lack of participants. There are many reasons for this. Big Pharma has a bad reputation, some of it deserved. In some cases, they have put profits ahead of safety, endangering the lives of participants, and at times, entire groups of people. And despite abundant evidence that clinical trial participants should better reflect the populations that are affected by disease indication, those in charge generally fail at achieving diversity in their studies.What are the results?

Clinical trials that fail because they don’t meet their enrollment requirements;

Medications that are approved and dispensed to groups of people with inconsistent results;

Ineffectiveness;

Or even worse, complications that were not foreseen during the clinical trial.

The answers the industry likes to propagate focus on “lack of trust” and/or lack of cooperation, particularly when the issue of diversity and ethnic groups arises. But I hereby propose a different reason:

The pharma industry is out of touch with today’s culture, both in motivation and communication. And this is evident in its standard recruiting operations.

Allow me to personify. It’s easy for me to do because it’s what I do. Both professionally and personally, I experience patient recruitment firsthand.

Allow me share a story. It’s a common story, in fact, one I could share at least once a week. Our company, Clinical Ambassador Health Inc., specializes in marketing communications for clinical trials and diversity recruiting of participants for studies across all therapeutic indications. We have a growing database of people who opt-in with us because we have bothered to ask them, and in some cases, because we’ve ignited an interest they didn’t heretofore realize they had. At any rate, we go about finding people who are interested in clinical trials, but there are many occasions wherein we don’t have a direct fit for one for which we are actively recruiting. Guess what we do then? We provide them with a free service. That’s right. We will help them identify an alternate study that might offer a fit for them to participate in.

Why do we go to the trouble, you ask? Several reasons:

We participate in clinical trials ourselves; I know how difficult it can be to find one.

We are concerned about the public’s perception of clinical research as a whole.

We answer to a higher god: Participants.

Back to my story. Two weeks back, we escalated a call from a person who was interested in a Type 2 diabetes study that we were recruiting for. As is fairly common, they didn’t quite meet the eligibility criteria. As this person had an A1c level over 9.0, I thought clinical trial participation might still be an important option for them to consider. So, I was happy to begin a search.

Because it’s still the gold standard for registered studies, I started my search with clinicaltrials.gov. As you may know, this search tool is rather intimidating even for providers to use. But as I have experience wading through the mire of it, I was able to identify a couple of “currently recruiting” trials in the participant’s area that looked promising. Next, I went looking for the site contact information always listed near the bottom of the site. I only found the sponsors’ information phone line. So, I called.

I now wish I could get that time back. I waded through four (4) levels of automated menus to finally get to a live person. At last. I explained who I was, why I was calling, and what I was looking for. After being placed on hold for several minutes, I then had to provide my address in order to get passed through to someone in their “medical” department which put me on the line with a pharmacist. I again explained what I was trying to do and asked for a local site contact for this clinical trial. I provided her with the NCT number and the medication it was studying. I was then placed on another hold, after which she took my information and told me she would pass it along. She informed me I would hear back within 7 days. Great.

REALLY??

A big part of the reason my boss allows me to continue working at Clinical Ambassador is because I— like she— won’t take ‘maybe’ for an answer. So naturally, I couldn’t stop at that. I used my signature deductive reasoning to cross reference which site was conducting this study. I then checked the site’s website and verified that they are in fact conducting diabetes studies. Then I call the site directly. And at exactly 2:45 in the afternoon my call goes straight to their voicemail. Since everybody is entitled to get busy in the afternoon, I left a message and also sent an email through their contact us form.Press “pause.” Let’s put this in perspective. The people that I spoke to at the pharma company’s site were nice. They were “ professional,” but I already spent 45 minutes getting the runaround just trying to refer one individual to a clinical trial that they actually seemed to qualify for! Add to this that I am not even requesting compensation for this referral. I am also rather experienced doing searches. I simply wanted to deliver great customer service to another would-be participant. Now, imagine a novice going through the same!

If not for Clinical Ambassador’s efforts in the community, this person might never have even reached out to inquire about a clinical trial to begin with. Let’s look at it from the participant’s lens. Would-be participants need to know how to navigate the clinicaltrials.gov site and narrow down the results to figure out ON THEIR OWN what might fit them. There are more patient-friendly search tools (Antidote.me is an example). But would-be participants still need to carve out the time to call the pharma company and wait. Or wait for them to reach out first. And wait again. And then wait some more. And if they do get a call back, too often it becomes a game of phone tag. Good luck finding participants who have open work day flexibility to answer their personal phones. How many of us answers calls from out-of-town or unknown numbers? How many communicate by IM or text instead of voice? A lot of people don’t even have their voicemail set up, and few have time (or privacy) to return personal calls during business hours. And THEN they would go through the same contact jujitsu at the site level. How many people forge through all of these obstacles? This set-up ignores how today’s society communicates as well as basic customer service and you know it. Rolling your eyes yet?

I learned from my many years of sales experience that a prospect is the most interested in a product when they initially reach out to you; and when they do, you better be able to provide them with what they require to make a decision to move forward. But the pharma industry and their various agents/assigns work business hours (at times, truncated hours), so that when we reach out, they are either too busy to talk, or the people we can reach seldom have the information we desire. And in today’s world, that is a recipe for failure – or in the case of clinical trials, “same old, same old.”

Is ANYBODY out there who can answer basic questions— ABOUT THEIR OWN STUDIES?

I know it seems like I’m indicting the industry for all of the holes in the system, but to be fair, some of it is not their fault. I’ll hand it to them for being mostly great at designing protocols, conducting research, running trials, and developing products. But let’s face it: the marketing and communication piece is not in their wheelhouse. NOT their expertise. If it was, they would embrace modern communication, they would tailor messages to their audiences, they would make someone available 24/7— with useful information— and with people who are actually eager to engage about their studies. They would offer a variety of communication modes, including social media, to connect with people where they live (yes, especially in person) and work to break down the barriers rather than implement new ones. They would use communication experts. You know, the ones who actually enjoy engaging with people and not just recruitment algorithms.

But on any given day, pharma refuses to acknowledge this disconnect. OR they’re steadfast in their position that they can do it themselves successfully. Whatever the reason they resist new ideas, and new approaches, from new companies, it isn’t working. What is clear for all to see is an attempt to conserve their recruitment budgets at the expense of piecemealing their efforts, or they trust single-source companies with slick, mostly detached, solutions. But the answer is not singular. It’s not all digital, or all local, or even completely in-person. The sweet spot is found using the feedback from a study’s coveted market, and is tailored to be a responsive combination of these methods. I remember a football coach sage advise that “if you are singular in your presentation, you will singularly fail!”

Rather than limit interaction on social media, industry can start now to do more to make it meaningful. Why would I suggest that? Because the powers-that-be think they have to control all feedback and avoid any negative comments that come in. I think the opposite. They need to “hear” people and be willing to respond appropriately. Attempting to shut people down doesn’t work, and it doesn’t breed believers or raving fans. And yes, this communication can coexist with IRB standards. When people spend hours a day on Facebook, Instagram, Twitter and other social platforms, there is insane amounts of untapped opportunity in which to engage them with the truth about clinical research. Why not take advantage of this free media that puts you virtually face-to-face with your market and the various digital communities where they live?

Riddle me this, too: Where are the gatekeepers at the clinical sites when anybody attempts to reach out? If a potential participant sees an ad on a Saturday afternoon or a Monday night, are you there to receive the call? NO! Crickets. But that is often when they are most interested! What is far from a real solution is thinking that sending them to voicemail or having your answering service take their name and number with a promise to call them back. (And really, what’s the difference?) This level of responsiveness (or lack thereof) does more harm than good. It frustrates people and leaves a bad taste in their mouths. Conversely, budgeting appropriately and being prepared to provide useful next-step information about their study of interest, and/or guiding them to other viable possibilities, and adding heaps of personal connection and rapport? Your likelihood of success just went up exponentially.

Many people in the profession don’t really seem to grasp the intersecting challenges faced by the participant population and the parameters of any given study. Nor do they seem to understand that getting participants interested and involved in clinical trials is really about connecting with people. It’s about meeting them where they are comfortable. And they are made more comfortable when you’ve been open, transparent, and accessible. And when you have provided them with the information they need— when and how it works best for them.

Sidebar: To anyone out there thinking, “Isn’t the best way to get participants through physicians’ patient databases? Not by a long shot. At least not in our experience. Maybe not for most trials! Another anecdotal experience: Clinical Ambassador was recruiting for a Phase IV trial for Entresto, a relatively new heart medication to treat patients with an ejection fraction under 40%. This is an approved combination therapy that in trials has shown to be more effective than standard treatments in many patients. But being new to market, it is not covered by most health insurances, and its cost are exorbitant— between $450 and $500 per month. The likelihood is high that many patients could not afford this drug on their own. So introducing these patients to a study that bypasses these costs is a no-brainer, right? Cardiologists have patients that are clinically in NEED of Entresto but cannot afford to fill the prescription. So they would be eager to offer them ACCESS to this medication. Right? Well, not so much, really. After presenting this option to exactly 48 Cardiologists within 30 miles of the study site, not a single one saw fit to have a person even explore the study. Why? Somebody explain it to us. But don’t suggest the physician referral model to me any time soon. I’ve still got blisters on my feet to show for it.

Big Pharma knows they face many obstacles to clinical trial recruitment. Historical baggage is an issue that they have created, and they still talk in circles around it. For example, in the African-American community, the word “Tuskegee” can be bantered around, particularly among our older demographics. But in engaging with the community, we have found that the community is welcoming to information about trials, and, when appropriately informed, is quite open to participating. We also offer testimonials about how cost-effective doing it right can be. But we’ve also seen far too often that those in control of the studies (and controlling the recruiting budgets) wait until the last minute and hide behind the barriers that they themselves have created as an excuse to not invest in the very efforts that could be game-changers.

Marketing communication is a an art unto itself. And not one that the executives, scientists, clinicians and accountants necessarily have in their wheelhouse. Only by accepting this, embracing it, and partnering with other entities that have the requisite skill set and bandwidth can we collectively become more successful in filling these studies with grateful patients and successfully completing them.

And to update my diabetes patient:

Two weeks in, still trying to connect with the study. Three studies from one drug company have actually closed, the site never called me back, and nobody else reached out to see if there were any other possible solutions in their clinical research portfolio.

And we wonder why we can’t fill these studies.

I’m reassuring you that there is a better way. We’re available 24/7 to show you how.